EPSOLAY®
(benzoyl peroxide) Cream, 5%
Papulopustular Rosacea
A diverse pipeline of topical skin medications
PDUFA
Goal Date
April 26, 2021
TWYNEO®
(benzoyl peroxide and tretinoin) Cream, 3%/0.1%
Acne Vulgaris
PDUFA
Goal Date
August 1, 2021
SGT-210
Palmoplantar Keratoderma
Results in
1H 2021
Currently in Phase 1
SGT-310
Psoriasis & Other Dermatological Indications
Formulation
SGT-510
Psoriasis & Other Dermatological Indications
Formulation
The safety and efficacy of these products have not been established.
Our Microencapsulation Technology
EPSOLAY®
Epsolay is an investigational topical cream containing benzoyl peroxide, 5%, for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process that is designed to slowly release benzoyl peroxide over time to the skin. The FDA has accepted our NDA for Epsolay with a PDUFA goal date set for April 26, 2021. If approved, Epsolay has the potential to be the first single-active benzoyl peroxide approved by the FDA as a prescription drug product.
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The safety and efficacy of Epsolay have not been established.
Epsolay is a registered trademark of Sol-Gel Technologies, Ltd.
Not an actual patient – actor portrayal
TWYNEO®
Twyneo is an investigational, antibiotic-free, fixed-dose combination of benzoyl peroxide, 3%, and tretinoin, 0.1%, cream for the treatment of acne vulgaris, using our proprietary drug-delivery technology. If approved, it has the potential to be the first acne treatment on the market that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are each approved as single-agent products for the treatment of acne. They are frequently prescribed together, however, they have not yet been marketed as a combination product because benzoyl peroxide causes degradation of tretinoin when combined in the same formulation. In Twyneo, each ingredient is encapsulated in a silica shell, which is designed to release the ingredients slowly over time. The FDA has accepted our NDA for Twyneo with a PDUFA goal date set for August 1, 2021.
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The safety and efficacy of Twyneo have not been established.
Twyneo is a registered trademark of Sol-Gel Technologies, Ltd.
Not an actual patient – actor portrayal
SGT-210
SGT-210 (erlotinib) is an investigational, topical epidermal growth factor receptor inhibitor in development for the treatment of palmoplantar keratoderma (PPK), a group of skin conditions characterized by thickening of the skin on the hands and soles of the feet, as well as basal cell carcinoma and squamous cell carcinoma, collectively referred to as non-melanoma skin cancer.
SGT-310 and SGT-510
We also intend to develop SGT-310 (tapinorof), an aryl hydrocarbon receptor (AhR) agonist, and SGT-510 (roflumilast), a phosphodiesterase 4 (PDE4) inhibitor, each as potential treatments for psoriasis and other dermatological indications.
The safety and efficacy of these products have not been established.